A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Zasocitinib in Children and Teenagers Aged 4 to Under 18 with Moderate-to-Severe Plaque Psoriasis

What this Trial Is About

Researchers are evaluating how well the medicine zasocitinib works, how safe it is, and how children and teenagers aged 4 to under 18 with moderate-to-severe plaque psoriasis respond to it. The study is a Phase 3 trial that includes two parts Part A with both children and teenagers, and Part B with only children. Initially, only teenagers who meet the study rules can participate, and children may join once enough information from other studies is available. Participants in Part A will be randomly assigned to receive either zasocitinib or a placebo for the first 16 weeks, after which all participants will receive zasocitinib for the remainder of the study. Participants in Part B will receive zasocitinib throughout the study. Dosages are given orally once daily, with doses adjusted by weight for children aged 4 to under 12 years, and a fixed dose for teenagers aged 12 to under 18 years. The study includes a double-blind placebo-controlled period followed by an open-label period. Participants will be involved for up to 4 years and 2 months, including up to 35 days for screening, 208 weeks of treatment, and a 4-week safety follow-up. During this time, participants will visit the study site multiple times for assessments, including skin evaluations, quality of life questionnaires, and blood tests to monitor drug levels and safety. Researchers will measure how many participants achieve clear or almost clear skin, improvements in psoriasis severity scores, quality of life improvements, and monitor the medicines concentration in the body.

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis